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Influence of Medication on Functional Connectivity

Primary Purpose

Prescription Drug Abuse (Not Dependent)

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxycodone Medication First
Placebo First
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Prescription Drug Abuse (Not Dependent)

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. males or females, ages 18-30
  2. for women of a child-bearing age, acceptable birth control methods or a negative pregnancy test prior to MRI scanning
  3. ability to provide written, informed consent
  4. eligibility and willingness to participate in fMRI scanning and to receive oxycodone
  5. normal weight, as indicated by a body mass index (BMI) between 18.5 to 25

Exclusion Criteria:

  1. current DSM-5 Axis I disorder
  2. any psychotropic medication or medication known to interfere with metabolism of opioids
  3. medical contraindication to participate in study activities (acute low-dose opioid admin) as determined by study physician
  4. known family history (first-degree relative) of opioid-use disorder or alcohol-use disorder
  5. not eligible for MRI scanning
  6. positive drug screen
  7. recent (past 6 months) medical or non-medical opioid-use
  8. current or previous chronic pain disorder
  9. significant lifetime use of prescription opioids (>7 days of consecutive medical use or nonmedical use on more than 5 occasions)

Sites / Locations

  • Magnetic Resonance Research Center at The Anlyan Center Yale School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Oxycodone Medication First

Placebo First

Arm Description

one hour before fMRI scan participants will be given a single dose 15mg immediate release oxycodone

one hour before fMRI scan participants will be given a single dose placebo.

Outcomes

Primary Outcome Measures

Change in functional connectivity following oxycodone administration
Functional connectivity is measured by functional magnetic resonance imagery (fMRI). Change in functional connectivity between placebo and oxycodone fMRI scans will be assessed.

Secondary Outcome Measures

Full Information

First Posted
July 2, 2018
Last Updated
June 14, 2022
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03612713
Brief Title
Influence of Medication on Functional Connectivity
Official Title
Influence of Medication on Functional Connectivity
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 30, 2018 (Actual)
Primary Completion Date
June 2, 2022 (Actual)
Study Completion Date
June 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will assess the effects of acute low-dose opioid administration on functional neuroimaging measures in healthy individuals
Detailed Description
This study will assess the effects of acute low-dose opioid administration on functional neuroimaging measures in healthy individuals (N=40, 20 male, 20 female). The objective of this research is to develop an understanding of factors that may influence individual variability on resting state functional connectivity in response to low-dose opioid administration with the longer term aim of understanding addictions vulnerability. Specifically, the proposed pilot research will explore the effects of single dose of oxycodone (15mg) on resting state functional connectivity and other common neuroimaging measures (e.g., diffusion MRI, structural MRI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prescription Drug Abuse (Not Dependent)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxycodone Medication First
Arm Type
Active Comparator
Arm Description
one hour before fMRI scan participants will be given a single dose 15mg immediate release oxycodone
Arm Title
Placebo First
Arm Type
Placebo Comparator
Arm Description
one hour before fMRI scan participants will be given a single dose placebo.
Intervention Type
Drug
Intervention Name(s)
Oxycodone Medication First
Other Intervention Name(s)
Oxycodone
Intervention Description
Participants will be given 15mg oxycodone one hour before fMRI scan. After at least 1 week wash out participants will be given placebo one hour before fMRI scan.
Intervention Type
Drug
Intervention Name(s)
Placebo First
Other Intervention Name(s)
placebo
Intervention Description
Participants will be given placebo one hour before fMRI scan. After at least 1 week wash out participants will be given 15mg oxycodone one hour before fMRI scan.
Primary Outcome Measure Information:
Title
Change in functional connectivity following oxycodone administration
Description
Functional connectivity is measured by functional magnetic resonance imagery (fMRI). Change in functional connectivity between placebo and oxycodone fMRI scans will be assessed.
Time Frame
Change in functional connectivity from initial fMRI scan to follow-up MRI scan, up to 4 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: males or females, ages 18-30 for women of a child-bearing age, acceptable birth control methods or a negative pregnancy test prior to MRI scanning ability to provide written, informed consent eligibility and willingness to participate in fMRI scanning and to receive oxycodone normal weight, as indicated by a body mass index (BMI) between 18.5 to 25 Exclusion Criteria: current DSM-5 Axis I disorder any psychotropic medication or medication known to interfere with metabolism of opioids medical contraindication to participate in study activities (acute low-dose opioid admin) as determined by study physician known family history (first-degree relative) of opioid-use disorder or alcohol-use disorder not eligible for MRI scanning positive drug screen recent (past 6 months) medical or non-medical opioid-use current or previous chronic pain disorder significant lifetime use of prescription opioids (>7 days of consecutive medical use or nonmedical use on more than 5 occasions)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Yip, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magnetic Resonance Research Center at The Anlyan Center Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States

12. IPD Sharing Statement

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Influence of Medication on Functional Connectivity

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